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news.Orexigen Therapeutics, a biopharmaceutical company, has filed a new drug application (NDA) to the FDA for Contrave (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity.
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Orexigen Therapeutics said that the NDA for Contrave is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.
All four trials in the COR Phase 3 program (COR-I, COR-II, COR-BMOD and COR- Diabetes) were randomised, double-blind, placebo-controlled trials, including a four week titration period. The co-primary endpoints were the proportion of patients achieving at least 5% weight loss and percent change in body weight compared to placebo.
In the COR program, Contrave clearly met the FDA efficacy benchmark: 48% and 56% of patients on Contrave32 lost at least 5% of their body weight in COR-I and COR-II on an intent-to-treat basis, as compared to 16% and 18% of placebo patients who lost at least 5%, respectively. Positive improvements were observed in cardiometabolic risk factors such as waist circumference, visceral fat, C-reactive protein, HDL cholesterol and triglycerides.
In the COR-Diabetes trial, patients with type 2 diabetes experienced significant weight loss and demonstrated meaningful reductions in HBA1c. Specifically, 45% of patients on Contrave32 lost at least 5% of their body weight on an intent-to-treat basis, compared to 19% of patients on placebo. Contrave patients also showed a 0.6% reduction in hemoglobin A1c (HbA1c) from baseline, compared to a 0.1% reduction in placebo.
Additionally, the patients treated with Contrave demonstrated positive improvement in quality of life, and in self reported exploratory measures of control of eating.
Mike Narachi, president and CEO of Orexigen, said: “The COR program was designed to address all the elements of the FDA guidance for weight loss and weight maintenance in patients with obesity. We believe that if approved, Contrave has the potential to serve the diverse needs of obese patients who currently have few treatment options.
“I want to extend my appreciation to the Orexigen team as well as the investigators and patients who participated in the COR program, which provided the high quality data supporting the submission. Having achieved this important milestone, we can now focus for the remainder of 2010 on managing the review and approval process for Contrave with the FDA, preparing for the launch of Contrave, and partnership.”